MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY E-Z LIFT BEACH CHAIR; POWERED BEACH CHAIR

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, a steris service technician arrived onsite to inspect the e-z lift beach chair and 4085 surgical table.The technician found no issue with the function or operation of the beach chair or surgical table; no repairs were required.Through follow-up with facility personnel, the technician learned that the beach chair had been improperly installed by user facility personnel as the clamps were not engaged upon the table side rails far enough for the threaded clamps to properly engage.The root cause of the reported event can be attributed to user error.The steris 4085 general surgical table operator manual states in the safety precautions section: "warning - personal injury hazard: when installing any table accessory, check for correct attachment and tighten securely (if appropriate).Do not use a worn or damaged accessory.Before using any accessory, ensure it has been installed properly." steris evaluated the reported event and determined it meets our reporting criteria under 21 cfr part 803; however, steris is not the manufacturer of the e-z lift beach chair.Steris notified the manufacturer, schuremed, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.A steris account manager will conduct in-service training on september 25, 2023, on proper use and operation of the e-z lift beach chair.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a non-steris e-z lift beach chair detached from their steris 4085 surgical table while adjusting the height subsequently causing the patient to fall off the table.No report of injury.The procedure was cancelled.

• Brand Name: E-Z LIFT BEACH CHAIR
• Common Device Name: POWERED BEACH CHAIR
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 17739127
• Report Number: 1043572-2023-00136
• Device Sequence Number: 5492828
• Product Code: GBB
• UDI-Device Identifier: 00810014601885
• UDI-Public: 00810014601885
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown